Urinary incontinence, in both males and females, is a significant medical problem. The use of bladder flow control devices, sometimes referred to as artificial sphincters or prosthetic urethral valves, is well known. Bladder flow control devices may be required due to loss of control or removal of the urinary sphincter muscle. The use of such intraurethral valve apparatus and general knowledge in the field of art can be evidenced by, for example, U.S. Pat. Nos. 4,553,533; 4,679,546; 4,969,474; 5,123,428 and 5,140,999.
One goal in the design of such devices is the safe and secure retention of the bladder control or valve device in the female urethra. It is desirable to have the placement of the bladder control apparatus in the urethra performed easily and nonsurgically. It is important that the device be securely retained once placed in the urethra. It is also important that the device be simple and inexpensive to manufacture, allowing for wide-spread adoption and use. Optimally, device surfaces exposed to the human body would be formed of polymeric materials, to lessen chances of inflammation in patients susceptible to irritation caused by contact with metals. A device should have both soft, flexible surfaces for retaining the device and strong materials within the valve portion. Various prior art devices have not met all of these criteria.